Effects of Casein Protein on Metabolism When Taken Prior to Sleep and in the Morning

Metabolism Clinical Trial

Official title:

Effects of Casein Protein on Metabolism When Taken Prior to Sleep and in the Morning

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06250270
• Other study ID #: 22-F-7
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: October 1, 2022
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of casein protein consumption both prior to sleep as well first thing in the morning on metabolism (increase satiety and appetite, lower resting metabolic rate, and lower blood sugar levels), when compared to nighttime protein or placebo consumption alone. Protein itself is a macronutrient that not only helps the body repair itself, and play a critical role in growth, it also aids in increasing satiety and decreasing appetite. Casein protein specifically is slow digesting dairy protein which may impact the body's metabolism for a longer period than other dairy proteins such as whey. The literature demonstrates nighttime protein ingestion prior to sleep increases metabolic rate and satiety the next morning. However, there appears to be no data on the metabolic effects of protein ingested both at night and in the morning.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: May 2025
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• male

• aged 18-30

Exclusion Criteria:

• lactose intolerant

• having known sleep issues

• being on a schedule that is not uniform week to week

• those who do not eat animal-based diets

• any known or suspected food allergies

• any known health conditions (cardiovascular disease, IBS, high blood pressure, diabetes, crohn's disease)

• those that have disordered eating

• unwillingness to take blood sugar four times a day

• being a female

Related Conditions & MeSH terms

• Metabolism

Intervention

Dietary Supplement:
• protein or placebo
casein protein (30g) or placebo (maltodextrin, 30g)

Locations

Country	Name	City	State
United States	Ohio University Exercise Physiology Lab	Athens	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	resting metabolic rate	indirect calorimetry to measure oxygen consumption (V02) and respiratory quotient (RQ)	baseline, during the intervention
Primary	blood glucose	fasting and pre-meal blood glucose	baseline, during the intervention
Secondary	dietary intake	food logs used to track food intake during all trial visits	during the intervention